Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

Bronchiolitis Obliterans Clinical Trial

Official title:

The Prevalence and Treatment of Sleep Disorders in Lung Transplant Recipients With BOS 2 & 3 and the Influence on Quality of Life and Daytime Activity.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02109237
• Other study ID #: HREC/13/QPCH/217
• Status: Withdrawn
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: The Prince Charles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.

Description:

Patients with Bronchiolitis Obliterans syndrome (BOS) 2 & 3 (25) will be matched 1:2 BOS 0 patients with similar demographics such as age, gender, BMI, time post transplant and renal dysfunction.Patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (QOL), any sleep issues they may have and be assessed by a doctor. Data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. All participants will undergo an overnight sleep study. If a sleep disorder is identified the participant will be offered appropriate treatment. All assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 & 3

• Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0

• Identified possible sleep related disorder

Exclusion Criteria:

• Subjects who do not provide informed consent

• Subjects unable to understand the study and related procedures

• Patients with a life expectancy of less than 6 months

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Disordered Breathing Central
• Sleep Wake Disorders

Intervention

Procedure:
• Assessment of sleep disorders and treatment if required
Assessment of sleep disorders and treatment if required

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
The Prince Charles Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of daytime activity, mobility and muscle strength	As part of standard care transplant patients are assessed for daytime activity, mobility and muscle strength every 6months this data will be used to assess any changes post treatment for sleep disorders	Baseline, 6 and 12 months post sleep study
Other	Lung function assessment	Assessment of lung function to determine any variation post treatment for sleep disorder.	Baseline, 6 and 12 months post sleep study
Primary	To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients	Using level one laboratory based polysomnograph	12 months
Secondary	Quality of life assessment using Rand SF36 standard survey	Participants will complete Rand SF36 standard survey for Quality of life. This will be completed at baseline visit and at 6 and 12 months post sleep study	Baseline, 6 and 12 months after sleep study